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Saturday, July 23, 2011

FDA's Enforcement Report for July 20, 2011

Okay, here we go! This, my dear friends, is the mother of all FDA reports. It is published weekly, and you will never believe how long it is--or for that matter what is on it.

Do you think that if you listen to the nightly news you will hear about all of the government issued recalls? You are so wrong.

The list begins mundanely enough with "Class I Foods" and a breakfast cereal. But read on! Everything from neonatal pumps and "reclaimed" blood products to whole blood, surgical instruments and reptile feed pelets are on this list!

If you or a loved one is having surgery, PLEASE take a scroll through this list. You may even want to print it out and make sure your doctor and his surgical team is aware of what's potentally an unknown danger.

CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

Labeling; Label Error on Declared Strength; label incorrectly states that the tablets are quarter strength and (1.1mg sodium fluoride) but should correctly state the tablets are full strength and 2.2mg (sodium fluoride).

Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products.

VOLUME OF PRODUCT IN COMMERCE

453,757 cases

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT

Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures. Recall # Z-2383-2011

As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product.

XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port shape.

BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing. Recall # Z-2608-2011

Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

VOLUME OF PRODUCT IN COMMERCE

5,440 plates

DISTRIBUTION

Nationwide, Canada, Columbia, Jamaica, South Korea, and Taiwan

___________________________________

PRODUCT

Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "Pro Trainers' Choice' Company, Inc.***. The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***". Recall # Z-2659-2011

The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue. The control panel printed circuit boards were missing a jumper connection across resistors R28 A, B, C, and D.

Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck; Part number 5290-744-100. Recall # Z-2794-2011

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Some people might call me a health nut, and probably I am--but not in the typical sense.
I am concerned with good food, quality nutrition and a healthy environment just like everyone else.
But I am just as concerned about the things that everyone takes for granted: Things like our medicines being safe to consume. Things like the instuments used by my surgeon being safe and reliable. And things like the toys my children and grandchildren play with not being toxic or outright deadly.
It takes time and research to discover how to best protect yourself as a consumer. And because of this, I write Totally Recalled so that people everywhere will have a one-stop place to find all of the newest recall and safety information on all products--ranging from everyday lettuce to medical blood plasma.